In an August 8 letter, attached hereto, to Dr. Deyton of the Center for Tobacco Products, CRE explains in detail the reasons that the FDA peer review fails to comply with the peer review guidelines mandated by the Data Quality Act.
CRE concludes that the FDA must take the following actions to come into compliance:
1. The agency must inform the public of how it can comment on the peer review plan and must consider any public comments.
2. Unless the agency specifically determines that it is not feasible and appropriate to do so, it must revise the peer review plan to state that it will make the agency’s draft assessment that will be peer reviewed available to the public prior to or during the peer review and sponsor a public meeting at which interested members of the public will have an opportunity to present oral comments to the peer reviewers.
3. Unless the agency specifically determines that it is not practical, it must revise its peer review plan to state that it will provide public comments on significant scientific issues to the peer reviewers during the peer review.
4. The peer review plan must be revised to state that peer review will be conducted on a panel basis rather than an individual/letter review basis in order to allow for a public meeting and oral presentations.
5. The agency must identify the outside organization that will select the peer reviewers (or which already has).
6. The peer review plan, and the charge to the peer reviewers, must be revised to include assessment of the potential for a “black market” in contraband menthol cigarettes and the potential impacts of such a development. The peer reviewers must include expertise pertinent to this issue, such as expertise in economics and criminology
7. The agency must inform the peer reviewers of the requirements and standards of the IQA and its guidelines/rules and inform them in the charge of the need to refrain from injecting policy/precautionary bias into their deliberations and conclusions.
8. The agency should disclose the charge to the public for comment and ensure that it contains the IQA information required by the OMB rules. The charge must also cover the contraband issue.
9. The agency should inform the public of the identity of the peer reviewers and their areas of expertise. This is necessary in order to allow the public to comment on item 10, below.
10. The agency must ensure that the selection of peer reviewers meets the requirements of the OMB rules for expertise, balance, lack of conflicts of interest, and independence.